Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Pertussis filamentous haemagglutinin, Quantity: 10 microgram/mL; Pertussis fimbriae 2 + 3, Quantity: 10 microgram/mL; Tetanus toxoid, Quantity: 80 IU/mL; Pertussis toxoid, Quantity: 20 microgram/mL; Diphtheria toxoid, Quantity: 60 IU/mL; Pertactin, Quantity: 6 microgram/mL
Sanofi-Aventis Australia Pty Ltd
Injection, suspension
Excipient Ingredients: aluminium phosphate; water for injections; phenoxyethanol
Intramuscular
5 X 0.5mL
(S4) Prescription Only Medicine
Tripacel is indciated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. Tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.
Visual Identification: Uniform,cloudy, white to off-white suspension.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1998-04-23
TRIPACEL ® T R I P A C E L ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY DOES MY CHILD NEED TRIPACEL? Tripacel is a vaccine. It is used to prevent three diseases, diphtheria, tetanus and whooping cough (pertussis), in infants and children. For more information, see Section 1. Why does my child need Tripacel? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN TRIPACEL? Do not use if your child ever had an allergic reaction to Tripacel or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR HAS HAD ANY OTHER MEDICAL CONDITIONS OR IS TAKING ANY OTHER MEDICINES. For more information, see Section 2. What should I know before my child is given Tripacel? in the full CMI. 3. WHAT IF MY CHILD IS TAKING OTHER MEDICINES? Some medicines may interfere with Tripacel and affect how it works. A list of these medicines is in Section 3. What if my child is taking other medicines? in the full CMI. 4. HOW TRIPACEL IS GIVEN? Tripacel is given by a doctor or nurse as an injection into muscle. More instructions can be found in Section 4. How is Tripacel given? in the full CMI. 5. WHAT SHOULD I KNOW AFTER MY CHILD IS GIVEN TRIPACEL? THINGS YOU SHOULD DO • KEEP AN UPDATED RECORD OF YOUR CHILD’S VACCINATIONS. • KEEP FOLLOW-UP APPOINTMENTS WITH YOUR DOCTOR OR CLINIC. LOOKING AFTER YOUR CHILD’S MEDICINE Tripacel is usually stored in the doctor’s surgery or clinic. However, if you need to store Tripacel: • keep in the fridge between 2-8°C. Do not freeze. For more information, see Section 5. What should I know after my child is given Tripacel? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? • Common side effects include local reaction around the injection site, drowsiness, decreased activity, irritability, eating and drinking less than usual, crying more than usual, screaming, nausea, vomiting, diarrhoea, fever greater than 37°C, itching Read the complete document
tripacel-ccdsv5-piv3-23mar20 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – TRIPACEL ® (ACELLULAR PERTUSSIS VACCINE, COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED)) 1 NAME OF THE MEDICINE Pertussis Vaccine-Acellular, Combined With Diphtheria and Tetanus Toxoids (Adsorbed). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tripacel is a sterile, isotonic suspension of purified acellular pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminium phosphate. Each 0.5 mL dose is formulated to contain: Diphtheria toxoid ( _Corynebacterium diphtheriae_ ) ≥ 30 IU (15 Lf) Tetanus toxoid ( _Clostridium tetani_ ) ≥ 40 IU (5 Lf) Pertussis toxoid (PT) 10 micrograms Pertussis Filamentous Haemagglutinin (FHA) 5 micrograms Pertussis Fimbriae 2 + 3 (FIM) 5 micrograms Pertactin (PRN) 3 micrograms Adsorbed on aluminium phosphate 1.5 milligrams (0.33 milligrams aluminium) The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Suspension for injection. After shaking, Tripacel is a white to off-white cloudy suspension for intramuscular administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tripacel is indicated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. tripacel-ccdsv5-piv3-23mar20 Page 2 of 13 Tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell or acellular) vaccines. 4.2 DOSE AND METHOD OF ADMINISTRATION For primary immunisation of infants, the following routine Tripacel immunisation schedule is recommended: one 0.5 mL dose administered at 2, 4 and 6 months of age. Read the complete document